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Food Safety

FDA should delay by three years the compliance date for changes to the Nutrition Facts Panel to align with the U.S. Department of Agriculture's implementation of the Bioengineered Ingredient Disclosure law, allowing companies to change their labels once rather than twice, the Grocery Manufacturers Association wrote in comments to the Department of Commerce.

The Trump administration is proposing a $40 million cut in FDA appropriations for the remainder of fiscal 2017, driven primarily by reductions in staffing, according to a document obtained by Inside Washington Publishers, which was recently sent to congressional appropriators.

Newly confirmed CMS chief Seena Verma and FDA chief-nominee Scott Gottlieb, if confirmed, face immediate orders from the White House to craft plans to reorganize their agencies to improve efficiency, shift functions to the states or local governments, and merge or shut down any functions for which costs aren't justified by public benefits or are redundant with work of other agencies.

States can use alternative payment models to bring prescription drug companies to the negotiating table and lower prices of drugs in the Medicaid drug rebate program without changing laws, researchers from Oregon Health & Science University told congressional advisers on Friday (March 3).

Congress' investigative arm is calling on the Trump White House to develop a national strategy to coordinate food safety oversight, which now spans across 16 federal agencies and 30 federal laws, saying in a recent report that a similar request made six years ago to the Obama White House fell flat.

President Donald Trump on Monday (Jan. 30) signed an executive order declaring for every new regulation introduced, two must be eliminated in a bid to cut regulations by up to 75 percent, and said any new regulatory burdens must be offset by other deregulatory policies so there are no new regulatory dollars spent during the remainder of fiscal 2017.

President Donald Trump put heads of executive departments and agencies on notice that no new rules or guidances should be sent to the Office of the Federal Register (OFR) until a Trump-appointed or designated agency head reviews and approves them, potentially putting controversial FDA draft guidances and notices on such hot-button issues as off-label use, new dietary ingredients, compounding and biosimilars on hold.

FDA rules didn't make the short-list of regulations targeted by a conservative think tank in ongoing meetings with congressional Republicans for repeal under the Congressional Review Act, but Freedom Partners is separately pushing an FDA reform agenda that includes state passage of right-to-try legislation and expediting U.S. approval of drugs cleared by other countries, sources with the group tell Inside Health Policy.

House Republicans are planning to vote on a set of bills this week that would increase Congress' ability to roll back rules passed in the final 60 legislative days of President Barrack Obama's administration, and pledged to dedicate much of the next two months toward overturning administrative rules finalized by the Obama administration.

Rep. Mark Meadows (R-NC) includes an FDA Food Safety Modernization Act final rule aimed at preventing terrorism attacks against the food supply on a list of more than 200 rules and regulations that he says “conservatives are requesting to be rolled back” in President-elect Donald Trump’s administration within the first 100 days in office, in a report published by his office Dec. 14.

Though Donald Trump has said little about his plans for FDA, food safety advocates are bracing for the possibility of regulatory rollbacks and budget cuts that could crimp implementation of the food safety law given the president-elect's regulatory reform and deficit-cutting pledges.

A food safety advocate worries a new draft FDA guidance outlining how food suppliers should disclose when specific hazards have not been controlled in food may put public health at risk, as suppliers can make a general disclosure for microbial hazards rather than detailing a specific hazard.

FDA's recently issued guidance on modifications to food product categories for food facility registration includes language that is binding on industry, to the surprise of industry lawyers and advocates.

FDA is gathering input on how to redefine "healthy" for food labeling claims in a move that could lead to a broader overhaul of food claim regulations. The agency is easing up on its enforcement as it gathers input on how to redefine "healthy" in response to a citizen petition from KIND requesting the claim be aligned with proposals from the 2015 Dietary Guidelines Advisory Committee and the 2010 Dietary Guidelines for Americans.

FDA's recent move to ban vinpocetine as a dietary ingredient after 20 years of it being marketed in supplements, coming soon after the agency updated its NDI draft guidance, should be a wake-up call to industry that FDA plans to consign dietary ingredients in supplements to "a more limited market than for conventional foods," according to an industry lawyer.

FDA food inspections, user fees and regulations governing food production hygiene, packaging and temperatures are overkill and should be eliminated, according to a now-deleted fact sheet published by Republican presidential nominee Donald Trump's campaign Thursday (Sept. 15).